DEFINITIVE LE is the largest peripheral atherectomy study conducted to
date with independent physician review of the outcomes. The study, which
enrolled 800 patients at 47 centers in the U.S. and Europe, demonstrated
the long-term effectiveness of directional atherectomy as a frontline
therapy for the treatment of peripheral arterial disease (PAD).
Directional atherectomy is a minimally invasive treatment that removes
plaque from the body and restores blood flow in the native artery.

“For the first time, the DEFINITIVE LE study has provided robust
evidence within a large and diverse PAD patient population,” said
Lawrence A. Garcia, M.D., Chief of Interventional Cardiology and
Vascular Interventions at St. Elizabeth's Medical Center in Boston.
“Directional atherectomy, with the SilverHawk and TurboHawk devices,
delivers patency results at 12 months post-treatment that are comparable
to those reported in stent studies—and with the important advantage of
not leaving anything behind in the vessel.”

DEFINITIVE LE 12-Month Efficacy and Safety Results

Clinical outcomes were improved by 30 days and sustained through 12
months of follow-up. Directional atherectomy with the SilverHawk and
TurboHawk devices delivered 12-month patency results that were
comparable to those reported in stent studies.

Among patients with claudication, primary patency (i.e., the treated
artery remained open) was 78% using a peak systolic velocity ratio
(PSVR) < 2.4 at 12 months. Notably, this rate did not differ between
patients with diabetes (77%) and those without diabetes (78%)—the first
such results to be shown in a prospective, powered analysis. Among
patients with critical limb ischemia (CLI - a severe form of PAD), 95%
were able to avoid a major unplanned amputation of the target limb. The
SilverHawk and TurboHawk devices were shown to have a strong safety
profile in the study, with low complication rates.

According to the American Heart Association, approximately 10 million
people in the U.S. are affected by PAD, which is one of the most common
vascular diseases and can lead to heart attack, stroke, amputation and
death. It occurs when arteries in the legs become narrowed or blocked by
plaque; these blockages can result in severe pain for patients, limited
physical mobility and non-healing leg ulcers.

"DEFINITIVE LE confirmed equivalent outcomes between diabetics and
non-diabetics in terms of patency and persistent clinical improvement up
to 12 months after treatment,” said Prof. Thomas Zeller, M.D., Head of
the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad
Kronzingen, Bad Krozingen, Germany. “Because diabetics have more
advanced PAD, re-stenose faster and are more difficult to treat than
non-diabetics, it is critical to preserve future treatment options in
this patient population. The confirmation from DEFINITIVE LE of
directional atherectomy as a treatment modality that provides strong
clinical outcomes in diabetics is a welcome and practice-changing
finding.”

Dr. Garcia and Prof. Zeller, together with Dr. James McKinsey, Chief of
the Division of Vascular Surgery and Endovascular Interventions at New
York-Presbyterian Hospital/Columbia University Medical Center, served as
Co-Principal Investigators for the DEFINITIVE LE study.

DEFINITIVE LE Study Design

The prospective, multi-center study comprised two cohorts—those with
claudication and those with CLI. A total of 1,022 lesions (up to 20 cm
in length) were treated with the Covidien SilverHawk or TurboHawk Plaque
Excision device. The study included a broad patient population, with 52%
diabetic, 45% female and 75% claudicants, and a pre-specified
sub-analysis comparing patency outcomes in diabetic and non-diabetic
patients.

Several controls were included to ensure rigor in the study. These
included Steering Committee oversight, adverse event adjudication by an
independent physician Clinical Events Committee and endpoint analyses
conducted by two different independent core laboratories—one that
analyzed acute angiographic results and another that analyzed duplex
ultrasound follow-up.

"We are pleased with the long-term results from our groundbreaking
DEFINITIVE LE study, which is unique among atherectomy studies conducted
to date because of the size of the study and the clinical rigor of
execution,” said Mark A. Turco, MD, Chief Medical Officer, Vascular
Therapies, Covidien. “We are continuing to invest in the DEFINITIVE
clinical program around new innovative treatments as a reflection of our
commitment to partnering with medical professionals to deliver the best
treatment for patients suffering with PAD.”

Final results from the landmark study were presented today during the
Late-Breaking Clinical Trials session at the Vascular InterVentional
Advances (VIVA)
Conference here.

About Covidien

Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2011 revenues of $11.6 billion, Covidien has 43,000
employees worldwide in more than 65 countries, and its products are sold
in over 140 countries. Please visit www.covidien.com
to learn more about our business.